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Ear zap eases back pain? new study tests nerve stimulation gadget

NCT ID NCT07529392

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a small device that gently stimulates a nerve in the ear can help people with long-term back pain. 48 adults will either get the ear stimulation plus standard rehab, or rehab alone, for 3 weeks. The goal is to see if the device improves daily function and reduces pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged ≥30 and ≤65 years * Indication: chronic myofascial/musculoskeletal back pain * normal function of spinal nerves * Intractable pain for more than 6 months * Patient on oral pharmacotherapy ≤ WHO II with no adequate response or intolerant * Severity according to "Leistungskategorie 2" of BVAEB classification, which means Barthel Index 35-80, 6-minute walk test 300-480 m OR ergometry 50-80%/0.75-1.25, ICF-Core-Sets grade 3 * Average pain over the last 4 weeks according to painDETECT ≥ 4 and ≤ 9 at baseline * ODI 20-80 at baseline * Patient understands the therapy and procedures, agrees to its provisions, and gives written informed consent prior to any procedures Exclusion Criteria: * Organic back pain (trauma, fracture, tumor, infection, severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions) * Indication for back surgery * Radicular pain * Back surgery within the last 6 months * New analgesics 2 weeks before baseline (paracetamol, NSAIDs, Metamizol, etc.) * Opioid analgesic therapy \> WHO II * Underwent other physical therapy modalities for back pain, also TENS, 2 weeks before baseline * History of vagus nerve stimulation or electrical auricular stimulation * History of vasovagal syncope * High BMI \> 35 kg/m² (Obesity Class 2 or higher) * Hemophilia or strong anti-coagulation medication * Autonomic disorders * Advanced stage or poorly controlled diabetes mellitus type I or II * Poorly controlled high blood pressure * Major psychiatric comorbidity (at the discretion of the PI) * Other serious clinically relevant co-morbidity * History of arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies * Infection, eczema, or psoriasis at application site (ear and neck) * Numbed and desensitized skin at the application site (ear and neck) * Chronic drug or alcohol abuse within the last 6 months * Pregnant or nursing female patients * Active implantable device * Open pension request * Currently participating in another clinical trial or participated over the last 3 months * Relevant change in concomitant treatment or medication during the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • BVAEB Rehazentrum Engelsbad

    RECRUITING

    Baden, Lower Austria, 2500, Austria

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